Kornimate/medical-research-clean huggingface dataset:
hilo-hf registry: high versus low spo2 oxygen therapy in patients with acute heart failure

Conditions: Acute Heart Failure

Summary: the hilo-hf registry is a single centre registry that will be performed to provide information on the usual baseline oxygen saturation (spo2) in patients presenting to ed with a primary ed diagnosis of ahf


Eligibility criteria:
inclusion criteria: * patients \>40 years of age presenting to the ed with ahf * with or without tested bnp * with or without admission to hospital for treatment of hf\\ * patients must be recruited within the first 24 hours of presenting to the ed. exclusion criteria: * patients on home oxygen * patients with known prior hypercapnic failure (paco2\>50 mmhg) * asthma * primary pulmonary hypertension * patients requiring urgent positive pressure ventilation or intubation or on \>10 l/min oxygen
evaluation of the accuracy & safety of the laserarcs nomogram

Conditions: Cataract; Astigmatism

Summary: evaluation of the accuracy and safety of the laserarcs femtosecond cataract surgery arcuate incision nomogram in patients undergoing cataract surgery and astigmatism reduction

femtosecond lasers allow the precise placement of arcuate keratotomy incisions in patients undergoing cataract surgery. though these surgical devices have been available for several years, most current nomograms designed to reduce astigmatism with these incisions are derived from those developed for metal or diamond knives. anecdotal reports from surgeons indicate that the previous nomograms have limited accuracy in the setting of femtosecond laser surgery. laserarcs.com is an online arcuate incision nomogram calculator initially developed on the basis of 12 months of data tabulation of patients undergoing femtosecond surgery with arcuate incisions. since that time, its user base has grown because of the high accuracy its model provides. currently over 3500 calculations are performed each month on this platform.

Eligibility criteria:
inclusion criteria: * patients with cataract and otherwise healthy eyes, not exhibiting any significant ocular morbidity that would be expected to influence outcome measures. * patients who are 22 years of age or older * patients whose preoperative astigmatism was greater than 0.5 d * patients who were implanted with a non-toric iol. * patients whose laser astigmatic keratotomy was planned using the laser arcs nomogram exclusion criteria: * patients with visually significant co-morbidities (corneal, retina, optic nerve disease) that could affect their satisfaction with surgery * patients with surgical complications either during or after surgery (capsule tears, iris trauma, decentered iol, cystoid macular edema, etc.) that would, in the judgment of the investigator, influence the outcome measures of the study. * patients with previous refractive surgery within the past 6 months prior to cataract surgery
virtual reality therapy for pain management at the emergency department

Conditions: Pain, Acute

Summary: rationale: prescriptions of analgesics, especially opioids, have doubled in the emergency department (ed) over the past decades in response to frequently reported undertreatment of pain in ed patients. consequently, there is a shift towards a more restrained utilisation of opioids at the ed. however, there are still few (non-)pharmacological alternatives. virtual reality (vr) therapy is a relatively new and promising technique in non-pharmacologic pain reduction and anxiolysis and shows positive results on pain relief and pain. objective: primary objective is to investigate the effect of vr on patient-reported pain outcomes in the ed. secondary objectives are to investigate the effect of vr on analgesics use, patient-reported outcomes, and process indicators and to identify barriers to implementation. last, subanalyses will be performed to compare the effectiveness of two types of vr: vr based on distraction (vrd) and vr based on focussed attention (vrf). study design: randomized controlled trial. study population: adults admitted to the ed with a nrs pain score of 4 (out of ten) or more and unacceptable pain. intervention: there will be a control group receiving usual care and a intervention group that receives additional vr therapy. main study parameters/endpoints: the main study outcome is the difference in patient-reported nrs pain score.


Eligibility criteria:
inclusion criteria: * patient ≥16 years admitted to ed * nrs pain at rest score ≥4 * pain not acceptable for patient * patient is willing and able to comply with the study protoc exclusion criteria: * patients initially treated by another physician than the emergency physician (ep). * emv \< 14 * history of dementia, seizures * severe hearing/visual impairment not corrected * headwounds or damaged skin with which comfortable and hygienic use is not possible. * presentation to the ed because of chronic pain (≥3 months) exacerbation * chronic opioid use (≥3 months) * psychiatric disorders interfering with patients' understanding of the study protocol and informed consent

Keywords: virtual reality therapy pain at rest emergency department
universal transvaginal cervical length screening program for prevention of preterm birth in singletons without prior preterm birth

Conditions: Preterm Birth

Summary: this is a non-blinded randomized screening trial of asymptomatic singleton pregnancies without prior spontaneous preterm birth who are randomized to either transvaginal ultrasound cervical length screening program (i.e. intervention group) or no screening (i.e. control group). women are consented and randomized at the time of their routine anatomy scan between 18 0/7 and 23 6/7 weeks. women randomized in the transvaginal ultrasound cervical length screening will receive a single transvaginal ultrasound cervical length measurement after the anatomy scan. the cervical length will be measured by operators with certification of competence in the technique.


Eligibility criteria:
inclusion criteria are: * singleton gestations * no prior sptb exclusion criteria are: * multiple gestations * history of sptb in a prior pregnancy * rupture of membranes at the time of randomization * known major fetal structural (i.e. defined as those that are lethal or require prenatal or postnatal surgery) or chromosomal abnormality * fetal death at the time of randomization * cerclage in situ at the time of randomization * pessary in situ at the time of randomization * vaginal bleeding at the time of randomization * women who are unconscious, severly ill, mentally handicapped, or under the age of 18 years.
embolization for the treatment of heel pain secondary to plantar fasciitis

Conditions: Plantar Fasciitis of Both Feet

Summary: this study evaluates the feasibility and safety of using lipiodol (ethiodized oil) as an investigational embolic agent for treating pain caused by plantar fasciitis. participants will undergo a minimally invasive procedure called plantar fascia embolization (pfe) to reduce inflammation and pain in the affected area. the study aims to assess changes in pain levels, foot function, and any potential side effects over a six-month follow-up period.

this study investigates the use of lipiodol (ethiodized oil) for plantar fascia embolization (pfe) to treat pain from plantar fasciitis. it focuses on evaluating safety, feasibility, and outcomes related to pain reduction and improved foot function.

Eligibility criteria:
inclusion criteria:participants aged 22 years or older. diagnosed with plantar fasciitis by an orthopedic or podiatry surgeon. ultrasound evaluation showing: increased plantar fascia thickness \> 4 mm. hyperemia in the plantar fascia near its proximal insertion or perifascial soft tissue. self-reported pain of at least 5/10 on the visual analog scale (vas). negative x-ray for acute fractures. refractory to at least 6 weeks of conservative therapies. able to provide written informed consent. - exclusion criteria:heel pain caused by stress fractures, nerve entrapment, or inflammatory conditions such as arthritis, gout, or bursitis. corticosteroid injection in the plantar fascia within 90 days prior to embolization. prior surgical repair or plantar fascia rupture. severe allergy to lipiodol or iodinated contrast media. diagnosis of peripheral arterial disease affecting the lower extremities. active workers' compensation claim for plantar fasciitis. pregnancy or breastfeeding. type 1 diabetes mellitus or significant renal dysfunction (gfr \ 2.0 mg/dl). sensory or motor neuropathy of the feet. active skin wounds on the plantar surface of the affected foot. -
agaricus blazei murill (abm) in patients with inflammatory bowel disease (ibd)

Conditions: Inflammatory Bowel Disease

Summary: based on the anti-inflammatory and stabilising effect of the abm, (agaricus blazei murill) based mushroom extract andosantm on cytokine release in blood in vivo and ex vivo in healthy volunteers after 12 days consumption, the aim in this study is to investigate whether same effect is valid in patients with ibd (inflammatory bowel disease). in addition, calprotectin an abundant cytosolic protein in neutrophils and a surrogate marker for degree of intestinal inflammation will be measured in blood and feces of these patients.


Eligibility criteria:
inclusion criteria: * moderate disease activity exclusion criteria: * no use of imurel (azathioprin) or anti-tnf treatment

Keywords: inflammatory abm ibd
g-csf+decitabine+bucy vs bucy conditioning regimen for raeb-1, reab-2 and aml secondary to mds undergoing allo-hsct

Conditions: Myelodysplastic Syndrome; Allogeneic Hematopoietic Stem Cell Transplantation; Conditioning

Summary: allogeneic hematopoietic stem cell transplantation (allo-hsct) appears to be an efficient tool to cure refractory anemia with excess blasts-1 (raeb-1), refractory anemia with excess blasts-2 (raeb-2) and acute myeloid leukemia (aml) secondary to myelodysplastic syndrome (mds). at present, the best conditioning regimen for raeb-1, raeb-2 and aml secondary to mds undergoing allo-hsct remains in discussion. in this prospective randomized controlled study, the safety and efficacy of g-csf+ decitabine + bucy and bucy myeloablative conditioning regimens in patients with raeb-1, reab-2 and aml secondary to mds undergoing allo-hsct are evaluated.

allo-hsct appears to be an efficient tool to cure patients with mds and aml secondary to mds. at present, the best conditioning regimen for mds and aml secondary to mds undergoing allo-hsct remains in discussion. bucy conditioning regimen is the standard myeloablative regimen for mds and aml secondary to mds undergoing allo-hsct. however, it appears to have higher relapse rate. to reduce the relapse rate, decitabine is added in the conditioning regimen. in this prospective randomized controlled study, the safety and efficacy of g-csf + decitabine + bucy and bucy myeloablative conditioning regimens in raeb-1, reab-2 and aml secondary to mds undergoing allo-hsct are evaluated.

Eligibility criteria:
inclusion criteria: * raeb-1, reab-2 and aml secondary to mds undergoing allo-hsct * 14-65 years exclusion criteria: * any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure) * patients with any conditions not suitable for the trial (investigators' decision)
effect of multifunctional nutrition tube on cerebral small vessel disease patients

Conditions: Cerebral Small Vessel Diseases

Summary: nasogastric tube feeding (ngt) has been widely used in cerebral small vessel disease (csvd) patients with dysphagia but has a significant risk of complications. intermittent oro-esophageal tube feeding (ioe) is an established enteral nutrition approach that can be used with comprehensive rehabilitation therapy. this study aims to explore the clinical effect of ioe vs. ngt on csvd patients with dysphagia. compared to ngt, ioe, as an enteral nutrition support mode, in csvd patients with dysphagia who received comprehensive rehabilitation therapy, showed advantages in improvement in dysphagia, nutritional status, adl, qol, pneumonia, and adverse events, which should be considered as the preferred approach.

nasogastric tube feeding (ngt) has been widely used in cerebral small vessel disease (csvd) patients with dysphagia but has a significant risk of complications. intermittent oro-esophageal tube feeding (ioe) is an established enteral nutrition approach that can be used with comprehensive rehabilitation therapy. this study aims to explore the clinical effect of ioe vs. ngt on csvd patients with dysphagia. this was a randomized controlled study with 60 csvd patients with dysphagia who received comprehensive rehabilitation therapy. patients enrolled were randomly divided into the observation group (with ioe, n=30) and the control group (with ngt, n=30). at admission and after treatment, video fluoroscopic swallowing study (vfss) and functional oral intake scale (fois), body mass index (bmi), serum albumin (alb), and hemoglobin (hb), modified barthel index (mbi) and world health organization quality of life assessment instrument brief version (whoqol-bref) were recruited to assess and compare dysphagia, nutritional status, activities of daily living (adl) and quality of life (qol). the incidence of pneumonia was recorded and compared.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of csvd; * must be able to cooperate with treatment and questionnaire investigation, (generally with a mini-mental state examination (mmse) score ≥ 24) ; * clinical diagnosis of dysphagia through the functional oral intake scale (fois) and video fluoroscopic swallowing study (vfss); * age between 40 and 70 years; * enteral nutrition support was required and feasible. * no history of prior stroke. exclusion criteria: * dysphagia related to other cerebrovascular diseases or caused by neurodegenerative diseases; * complicated with severe liver and kidney failure, tumors, or hematological disorders; * simultaneously need to undergo other therapy that might affect the outcomes of this study; * pregnant or nursing females.
a study to compare the efficacy and safety of pegvisomant to that of sandostatin lar depot in patients with acromegaly

Conditions: Acromegaly

Summary: the purpose of the study is to determine if pegvisomant is more efficacious than sandostatin lar depot in normalizing igf-i levels in treatment naive patients with acromegaly.


Eligibility criteria:
inclusion criteria: * diagnosis of acromegaly * igf-i levels \>=1.3xuln (upper limit of normal) at screening * no history of radiotherapy or prior treatment with other drugs for acromegaly * minimum of two months must have elapsed post surgery prior to screening exclusion criteria: * presence of other conditions that may result in abnormal gh (growth hormone) and/or igf-i concentrations * ast/alt \>= 3xuln (upper limit of normal) * pituitary adenoma within 3mm of optic chiasm confirmed by recent mri * visual field defects (except post surgical stable residual defects) * unable to self administer drug
discontinuation of orthokeratology on eyeball elongation in myopic children

Conditions: Myopia

Summary: the primary aim of this study is to compare eyeball elongation in existing ortho-k subjects who stop the treatment with subjects who continue ortho-k lens wear and control subjects wearing single-vision glasses.

children wearing ortho-k have been shown to have slower rate of myopic progression than those wearing single-vision spectacles (cho et al. 2005) or soft lenses (walline et al. 2009). both studies showed that the effect of myopic control was most significant during the first six months of the treatment. it is unknown whether the myopic control effect would dissipate upon the discontinuation of the treatment or whether the myopic control effect only happened in the first six month of lens wear and was maintained thereafter. the current study aims at evaluating the effect of discontinuation of ortho-k treatment on myopic control in children who are currently on the treatment. this knowledge is necessary and important as patients/parents have concerns about the permanent dependency on ortho-k once they enrolled in the treatment. children who have been on the treatment for two years and have recently completed the myopic control studies at the hong kong polytechnic university, i.e. the romio, to-see and hm-pro studies, will be invited to participate in this 14-month study. ortho-k subjects will be randomly assigned to study group or the ortho-k control group. the study group subjects will be required to stop lens wear for 7 months at the completion of the previous study (phase i) and resume lens wear for next 7 months (phase ii). the ortho-k control group subjects will be required to continue the current treatment for another 14 months. control subjects in the existing myopic control studies will be required to continue using the same treatment, i.e. single-vision glasses, for another 14 months. rate of myopic progression among the 3 groups and at the two study phases will be determined and compared.

Eligibility criteria:
inclusion criteria: * age 8-14 years old (inclusive) * subjects who have completed the romio, to-see or hm-pro studies at the hong kong polytechnic university * willingness to be randomized into groups (for ortho-k subjects) * availability for follow-up for at least 14 months exclusion criteria: * non-compliance to the follow up schedule * non-compliance to the assigned optical correction (i.e. single-vision glasses or ortho-k lenses) * contraindication for contact lens wear and ortho-k (e.g. limbus to limbus corneal cylinder and dislocated corneal apex) * systemic or ocular) conditions which may affect contact lens wear (e.g. allergy and medication) * systemic or ocular conditions which may affect refractive development (e.g. down syndrome, ptosis)

Keywords: children corneal reshaping myopia myopia progression orthokeratology
impact of covid-19 pandemic on out-of-pocket costs, lost wages, and unemployment in patients with breast cancer undergoing breast surgery

Conditions: Breast Ductal Carcinoma In Situ; COVID-19 Infection; Hereditary Breast Carcinoma; Invasive Breast Carcinoma

Summary: this study investigates the impact of covid-19 pandemic on out-of-pocket costs, lost wages, and unemployment in patients with breast cancer undergoing breast surgery. post-mastectomy reconstructive patients are at high risk for financial toxicity (adverse effects of escalating health care cost on well-being). the goal of this study is to collect information about financial costs patients may have as a result of surgical treatment for cancer with or without breast reconstruction and to learn if covid-19 affects patient costs of breast reconstruction. this may help researchers demonstrate the financial consequences of undergoing breast surgery.

primary objectives: i. obtain comprehensive score for financial toxicity (cost) questionnaire data from the patients who are undergoing any form of mastectomy (with or without breast reconstruction). ii. to determine which patients are at higher risk of financial toxicity while pursuing breast reconstruction. iii. assess if financial toxicity or distress is associated with worse breast-questionnaire (q) performance as well as quality of life. iv. identify relationships between coronavirus disease 2019 (covid-19) related productivity losses and financial toxicity. outline: patients complete up to 4 electronic questionnaires over 15 minutes before surgery and at 6, 12, and 24 months after surgery. after completion of study, patients will be followed up for 1 year.

Eligibility criteria:
inclusion criteria: * have an indication for surgical treatment of invasive breast cancer or ductal breast carcinoma in situ (dcis) or prophylaxis in the setting of genetic mutations or strong family history * english-speaking * able to complete consent * able to fill out computer survey material exclusion criteria: * non-english-speaking * those with recurrent or metastatic disease or concurrent primary cancers * patients undergoing breast conservation therapy will also be excluded from the study
multicenter, prospective study for urinary exosomal biomarkers of kidney allograft tubulointerstitial fibrosis

Conditions: Renal Fibrosis; Kidney Transplant Failure

Summary: the investigators aim to identify urinary exosomal biomarkers that represent the extent of graft fibrosis from deceased donor kidney transplantation. urinary samples will be collected from deceased kidney donors at the time of procurement and zero-day kidney graft biopsy will be performed at the time of transplant. the association between urinary exosomes and the degree of graft fibrosis will be analyzed to identify biomarkers that represent fibrosis. the correlation between these biomarkers and graft long term outcomes will be investigated.

interstitial fibrosis and tubular atrophy (ifta), previously known as chronic allograft nephropathy (can), is diagnosed by pathologic changes involving all parts of the renal parenchyma and is one of the factors impacting graft survival and outcome. currently, there is no standard to predict allograft fibrosis status at the time of procurement. noninvasive biomarkers are necessary to monitor allograft status and to predict long-term outcomes. the investigators aim to conduct a multicenter prospective study to identify urinary exosomal biomarkers that represent the extent of graft fibrosis from deceased donor kidney transplantation. urinary samples will be collected from deceased kidney donors at the time of procurement and zero-day kidney graft biopsy will be performed at the time of transplant. the zero-day biopsy tissue will be stained with masson's trichrome staining, collagen i, iii, iv immunostaining to evaluate the degree of fibrosis. also, by ultracentrifuge, we will extract urinary exosomes and perform proteomics analysis and rna-sequencing. the association between urinary exosomes and the degree of graft fibrosis will be analyzed to identify biomarkers that represent fibrosis. the correlation between these biomarkers and graft long term outcomes will be investigated.

Eligibility criteria:
inclusion criteria: * end-stage renal disease patients receiving kidney transplantation from deceased donors who have the ability to provide content for this study exclusion criteria: * multi-organ transplantation candidate or history of previous transplant, history of extra-renal solid organ or bone marrow or stem cell transplant, active infection, history of recent intoxication of alcohol or substance abuse within 24 weeks
early neurophysiological markers of language impairments

Conditions: Development, Infant; Development, Language; Developmental Language Disorder; Learning Disabilities

Summary: the present project aims at identifying very early electrophysiological risk markers for language impairments. the long-term goals of the study include the characterization of learning developmental trajectories in children at high risk for language impairments. in this project, all the infants of the medea babylab cohort are followed-up until school age. since these infants have complete information on early electrophysiological markers, the final goal of the project is the characterization of their learning developmental trajectories and the construction of a multi-factor prognostic model that includes the neurophysiological processes underlying basic-level skills as potential biomarkers for predicting later reading and spelling skills.


Eligibility criteria:
inclusion criteria: * healthy infants aged \<24 months * infants with and without familial risk for language impairments (infants are assigned to the group with familial risk if at least one first-degree relative had a certified (clinical) diagnosis of language impairment or learning disability * both parents are native-italian speakers exclusion criteria: * gestational age \< 37 weeks and/or birth weight \< 2500 grams * apgar scores at birth at 1' and 5' \< 7 * bayley cognitive score \< 7 * presence of certified diagnosis of intellectual deficiency, attention-deficit disorder, sensorial and neurological disorders, or autism within first-degree relative